Pilot Study on Fecal Microbial Transplant in Adults with Multiple Sclerosis
This pilot study is designed to explore whether fecal microbial transplant (FMT) can serve as a potential therapy for multiple sclerosis (MS). The study includes adults with clinically definite MS who are either untreated or on specific therapies. Participants will receive a single FMT procedure comprising 30 oral capsules containing fecal material. No results from the study are currently available.
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Why it matters
This research could provide insights into a novel treatment approach for MS, which currently lacks effective therapies for some patients. Understanding if FMT is viable could broaden treatment options in managing MS symptoms.
What this does not prove
Since no results are posted and planned enrollment and endpoints are not findings, the potential effectiveness or safety of FMT for MS remains unproven.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not applicable
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (7)
subjectsDetermine whether the FMT has any adverse impact, relative to baseline, on study participants' neurological status, relative to baseline\n\nThe study population will consist of adults with clinically definite MS who are currently untreated with any disease-modifying therapy or are being treated with glatiramer acetate or interferon beta.
randomizedWomen who are pregnant, lactating, planning to become pregnant, and/or not using an effective method of contraception (women of childbearing potential will undergo a pregnancy test, and will be excluded from the study if results are positive);\n29.
controlledWomen who are pregnant, lactating, planning to become pregnant, and/or not using an effective method of contraception (women of childbearing potential will undergo a pregnancy test, and will be excluded from the study if results are positive);\n29.
regulatory approvalPrevious use of any of the following FDA-approved disease-modifying drugs within 12 months of study entry, including natalizumab, fingolimod, siponimod, ozanimod, teriflunomide, diroximel, ocrelizumab, ofatumumab, and/or dimethyl fumarate; or any of the following off-label therapies, including rituximab and cyclophosphamide;\n10.
primary endpoint"measure": "Change in engraftment of donor microbiome in stool samples",
findingsThe goal of this pilot study is to determine whether fecal microbial transplant (FMT) has the potential to be an effective, safe and tolerable therapy for the treatment of multiple sclerosis (MS).
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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